FSP - Scientist - Pharmaceutical Development

Thermo Fisher Scientific•San Diego, CA

3d•Onsite

About The Position

This is a fully onsite role based at our customer’s site in San Diego, CA (Carmel Valley area). Thermo Fisher's clinical research business is a leading global contract research organization and world leader in serving science. We are passionate, deliberate, and driven by our mission – to enable our customers to make the world healthier, safer, and cleaner. Our Laboratories Functional Service Partnership (FSP) team plays a direct role in advancing drug development by creating sustained groups of talent within our customers’ organizations to provide long-term support. Through this collaborative approach, our professionals bring their commitment to excellence, industry knowledge, and operational strength directly into customer environments, helping to enhance capabilities and advance the delivery of life-changing therapies. As a Scientist you will work as a key lab work contributor and focus on building lab capability for drug product development, support clinical phase development studies for a diverse portfolio of small molecule therapeutics. The successful candidate will be able to adapt quickly to a highly collaborative and fast-paced team environment, flexibly supporting multiple development projects. Key areas of focus include supporting pilot scale manufacturing equipment setup/maintenance, phase appropriate formulation and drug product process development, cGMP processes and documentation, in process physical properties characterization, and independent laboratory operations management to support a scientific staff.

Requirements

Experience with setup and operation of small molecule unit operations/models such as Styl’One compaction simulator, Gerteis roller compactor, manual encapsulation/ProFill, ILC Dover applications for HP/C handling, Mini/MidiGlatt, Comil, and V-blenders.
Experience with characterization technologies such as Malvern-particle size analyzer, bulk/tap density analysis, and HPLC analysis.
Bachelor's degree in lab sciences such as Chemistry, Biochemistry, Pharmaceutical Sciences, or similar Scientist: Previous experience that provides the knowledge, skills, and abilities to perform the job (comparable to 2+ years’) OR Masters degree
In-depth understanding of cGMP conduct for batch production processes, good documentation practices, and laboratory operations.
Hands-on experience in commonly used characterization instruments for a solid oral drug product lab; A good understanding of the principles of those instruments; ability to independently troubleshoot minor instrument issues.
Ability to interpret testing results, identify trends and out-of-trend data points, summarize findings, and make scientific conclusions
Excellent at team coordination and training associated with operational excellence and safety implementation.
Ability to participate in the design and independently perform development formulation studies for small molecule and biologic drug candidates under direction of scientific staff.
Understanding of the basics of GXP compliance and practices is a plus
Strong organizational and technical problem-solving abilities
Ability to effectively prioritize tasks and manage multiple projects
Acts as a team player and collaborator who can listen effectively and communicate in an open, clear and timely manner
Well-trained in Good Documentation Practices (GDP) within the pharmaceutical industry
Develops knowledge of scientific principles, methods, and techniques
Solid knowledge and experience working with pharmaceutical manufacturing to ensure safety compliance

Nice To Haves

Experience supporting manufacturing development and process development is a plus

Responsibilities

Execute R&D drug product experiments, including excipient compatibility, physicochemical characterization, and testing using state-of-the-art analytical instrumentation and techniques.
Support Pharmaceutical Development team members with process execution, scale up, and materials generation.
Develop and maintain electronic laboratory notebooks to ensure accurate documentation.
Collaborate effectively within a team setting to lead the preventive maintenance coordination, troubleshooting, calibration, and repair activities for drug product manufacturing equipment.
Serve as liaison for equipment service vendors, managing maintenance schedules and spare parts inventory.
Maintain comprehensive equipment inventory including spare parts, change parts, tools, and tooling.
Ensure efficient day-to-day laboratory operations through systematic assembly, disassembly, and relocation of product development equipment while maintaining compliance with safety protocols.
Coordinate laboratory schedules, optimize resource utilization across teams, and identify opportunities to streamline laboratory processes to drive operational efficiency.
Manage laboratory inventory and supplies, ensuring optimal stock levels through strategic ordering and collaboration with colleagues.
Coordinate shipping and receiving of laboratory materials while maintaining proper documentation.
Implement safety protocols through proper equipment maintenance and laboratory cleanliness standards.
Support chemical hygiene and waste disposal programs in coordination with facilities team.
Contribute to laboratory upgrades and safety improvements.
Collaborate with late-stage drug product development team to understand requirements and enhance laboratory operations.

Benefits

competitive remuneration
annual incentive plan bonus
healthcare
A choice of national medical and dental plans, and a national vision plan, including health incentive programs
Employee assistance and family support programs, including commuter benefits and tuition reimbursement
At least 120 hours paid time off (PTO)
10 paid holidays annually
paid parental leave (3 weeks for bonding and 8 weeks for caregiver leave)
accident and life insurance
short- and long-term disability
Retirement and savings programs, such as our competitive 401(k) U.S. retirement savings plan
Employees’ Stock Purchase Plan (ESPP)